- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05272059
Multiple Ascending Dose Study of MHS552 in Adults With Type 1 Diabetes Mellitus
A Randomized, Investigator and Participant Blinded, Placebo Controlled, Multiple Ascending Dose, Two Part Design Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of MHS552 in Adults With Type 1 Diabetes Mellitus (T1DM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a Phase 1b, randomized, investigator and participant blinded, placebo controlled, multiple ascending dose (MAD) study in adults with type 1 diabetes mellitus (adults aged 18-45 years, inclusive, diagnosed with T1DM within 5 years at the time of screening). This MAD study will be conducted in two sequential parts, Part A and Part B.
In Part A, after an screening period of up to 28 days, participants will be randomized (in a 3:1 ratio) to MHS552 or placebo administered subcutaneously (s.c.) weekly for four weeks of treatment. Part A will consist of up to 3 cohorts (low, medium, high dose), with approximately 4-8 participants completing each cohort (total of approximately 16 participants). Participants will be followed-up during 8 weeks post last dose. The total duration of study participation of Part A is approximately 106 Days.
In Part B, after a screening period of up to 28 days, approximately 12 participants will be randomized (in a 2:1 ratio) to MHS552 or placebo administered s.c. weekly for 12 weeks of treatment (dose level 4). Participants will be followed-up during 8 weeks post last dose with End of Study (EoS) visit at Day 134. The total duration of study participation of Part B is approximately 162 Days.
Study Type
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult men and women ages 18 to 45, inclusive, body weight between ≥40 to ≤150 kg, inclusive, with T1DM, a maximum of 5 years from T1DM diagnosis at screening.
- Evidence of one or more T1DM autoantibody(ies) including glutamic acid decarboxylase (anti GAD), protein tyrosine, phosphatase-like protein (anti-IA-2); zinc transporter 8 (anti-ZnT8); islet cell (cytoplasmic) (anti-ICA)
- Residual pancreatic β-cell function (fasting C-peptide >100 pmol/L [0.30 ng/mL] or random C peptide >200 pmol/L [0.60 ng/mL])
Exclusion Criteria:
- History of hypersensitivity to drugs of similar biological class, IL-2 protein analogues, or immunoglobulin (IgG1) proteins, hypersensitivity to any components of the study drug, or history of severe hypersensitivity reaction or anaphylaxis to biological agents, e.g. human monoclonal antibody.
- Use of other investigational drugs or use of immunosuppressive agents at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or longer if required by local regulations.
- Diabetes forms other than autoimmune type 1 such as maturity-onset diabetes of the young (MODY), latent autoimmune diabetes of the adult (LADA), acquired diabetes (secondary to medications or surgery), type 2 diabetes by judgement of the investigator.
- Diabetic ketoacidosis within 2 weeks.
- Polyglandular auto-immune disease, including but not limited to: Addison's disease, pernicious anemia, celiac sprue and psoriasis. Treated, stable Hashimoto's thyroiditis is not exclusionary.
- History of capillary leak syndrome (CLS).
- Ongoing, and up to 2 weeks prior to screening, initiation of medications or change in dose of medications that may affect glucose control (e.g, systemic steroids, thiazides, beta blockers).
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A: Cohort 1 - MHS552 low dose
Participants will receive MHS552 low dose once weekly subcutaneously for 4 weeks
|
MHS552 will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B)
|
Placebo Comparator: Part A: Cohort 1, 2, 3 - Placebo
Participants will receive placebo once weekly subcutaneously for 4 weeks
|
Placebo will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B)
|
Experimental: Part A: Cohort 2 - MHS552 medium dose
Participants will receive MHS552 medium dose once weekly subcutaneously for 4 weeks
|
MHS552 will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B)
|
Experimental: Part A: Cohort 3 - MHS552 high dose
Participants will receive MHS552 high dose once weekly subcutaneously for 4 weeks
|
MHS552 will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B)
|
Experimental: Part B: MHS552
Participants will MHS552 (dose to be determined) once weekly subcutaneously for 12 weeks
|
MHS552 will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B)
|
Placebo Comparator: Part B: Placebo
Participants will receive placebo once weekly subcutaneously for 12 weeks
|
Placebo will be administered once weekly as subcutaneous injection for 4 (Part A) or 12 weeks (Part B)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Time Frame: Part A: up to 12 weeks; Part B: up to 20 weeks
|
Numbers of participants with AEs and SAEs including vital signs, electrocardiograms (ECG) and laboratory results
|
Part A: up to 12 weeks; Part B: up to 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under Plasma Concentration-time Curve calculated to the end of a dosing interval (AUCtau) for MHS552
Time Frame: Part A: up to Day 78; Part B: up to Day 134
|
Characterize the AUCtau profile following multiple doses of MHS552
|
Part A: up to Day 78; Part B: up to Day 134
|
Maximum ObservBlood Concentrations (Cmax) for MHS552
Time Frame: Part A: up to Day 78; Part B: up to Day 134
|
Characterize the Cmax profile following multiple doses of MHS552
|
Part A: up to Day 78; Part B: up to Day 134
|
Time to Reach Maximum Blood Concentrations (Tmax) of MHS552
Time Frame: Part A: up to Day 78; Part B: up to Day 134
|
Characterize the Tmax profile following multiple doses of MHS552
|
Part A: up to Day 78; Part B: up to Day 134
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMHS552B12101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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